Klonafen

Package leaflet: Information for the patient

Klonafen, 0.5 mg, tablets
Klonafen, 2 mg, tablets
Clonazepamum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Klonafen is and what it is used for
2. Important information before taking Klonafen
3. How to take Klonafen
4. Possible side effects
5. How to store Klonafen
6. Contents of the pack and other information

1. What Klonafen is and what it is used for

Klonafen contains the active substance clonazepam, which belongs to a group of medicines called
benzodiazepines.
Klonafen is used when there is no response to other medicines in the treatment of most types of epilepsy,
particularly absence seizures, including atypical absence seizures, myoclonic-astatic seizures, and tonic-clonic seizures.

2. Important information before taking Klonafen

Do not take Klonafen if the patient is allergic to:

• clonazepam or any of the other ingredients of this medicine (listed in section 6),
• other medicines in the benzodiazepine group, such as diazepam, flurazepam and temazepam. Do not take Klonafen if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before starting treatment with Klonafen.

Do not take Klonafen if the patient has:

• severe breathing difficulties;
• severe liver function disorders;
• problems with alcohol or psychoactive substance abuse (prescription medicines or drugs);
• coma. Do not take Klonafen if any of the above situations apply to the patient. If in doubt, consult a doctor or pharmacist before starting treatment with Klonafen.

Warnings and precautions
Suicidal thoughts and behaviour
In a small number of patients treated with antiepileptic medicines such as clonazepam, thoughts of self-harm or suicidal thoughts have occurred. If such thoughts occur at any time during treatment, contact a doctor immediately.
Before starting treatment with Klonafen, talk to a doctor or pharmacist if:

• The patient has kidney, liver or respiratory diseases.
• The patient has been diagnosed with myasthenia gravis (characterized by muscle weakness and rapid fatigue).
• The patient regularly consumes alcohol, takes medicines for non-medical purposes, or uses drugs, or has previously had problems with alcohol, medicine or drug abuse.
• The patient has been diagnosed with a condition called sleep apnoea syndrome (in which breathing stops during sleep).
• The patient experiences ataxia (may include tremor and instability, slurred speech or rapid eye movements).
• The patient has been diagnosed with a rare inherited blood disorder called porphyria.
• The patient is elderly or debilitated; the doctor may adjust the dose.
• The patient has previously had depression and/or suicide attempts.

Psychoses
Benzodiazepines are not recommended as first-line treatment for psychotic disorders.
Memory impairment (memory disorders)
This medicine, when used at the dose prescribed by a doctor, may also cause transient memory disturbances (anterograde amnesia). This means, for example, that activities performed after taking the medicine may not be remembered. This effect may be associated with inappropriate behaviour. The risk of anterograde amnesia increases with higher doses (see section 4).
Nervous system and musculoskeletal system disorders
Adverse effects related to the nervous system and skeletal muscles, as well as fatigue, which are relatively common and usually transient, typically resolve spontaneously or after dose reduction during treatment. These can be partially avoided by gradually increasing the dose at the beginning of treatment. Particularly during long-term treatment and at high doses, reversible disorders such as dysarthria (speech disturbances), disturbances in gait and movement coordination (ataxia), or nystagmus and visual disturbances (double vision) may occur.
Psychological and paradoxical reactions
It is known that benzodiazepines may cause reactions opposite to those expected (so-called paradoxical reactions), such as motor restlessness, nervousness, irritability, aggression, anxiety, delusions, anger, nightmares, hallucinations, psychoses, inappropriate behaviour and other undesirable behavioural effects (see section 4). In such cases, treatment with this medicine should be discontinued according to the doctor's instructions.
These paradoxical reactions occur more frequently in children and adolescents, as well as in elderly patients (section 3 "Discontinuation of Klonafen treatment").
Discontinuation of treatment/withdrawal symptoms:
Withdrawal symptoms may occur especially after ending long-term treatment, particularly at high doses. Withdrawal symptoms may include tremor, sweating, restlessness, sleep disturbances and anxiety, headache, diarrhoea, muscle pain, panic attacks, tension, motor restlessness, mood swings, confusion, irritability and epileptic seizures (which may be related to the underlying disease).
In severe cases, the following symptoms may occur: feeling detached from oneself or surroundings, increased sensitivity to sound (hyperacusis), hypersensitivity to light, noise and physical contact, tingling and numbness in hands and feet, hallucinations.
Because the risk of withdrawal symptoms is greater after abrupt discontinuation of treatment, abrupt withdrawal of clonazepam should be avoided, and treatment should be discontinued by gradually reducing the dose – even in the case of short-term treatment (see section 3).
Tolerance
Tolerance to clonazepam may develop after prolonged use.
Infants and young children
In infants and young children, this medicine may increase bronchial secretions and saliva production; therefore, ensure that airway patency is maintained.
If any of the above situations apply to the patient or if in doubt, consult a doctor or pharmacist before taking Klonafen.
Klonafen and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Klonafen may affect the action of other medicines. Likewise, some other medicines may affect the action of Klonafen.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• centrally acting medicines, e.g. those used in epilepsy treatment (such as carbamazepine, lamotrigine, hydantoins, barbiturates, phenobarbital, phenytoin, primidone or valproates), opioid analgesics, general anaesthetics, sleeping tablets, psychotropic medicines, antidepressants, centrally acting antihypertensive medicines
• fluconazole (an antifungal medicine).

Concomitant use of Klonafen and opioids (strong painkillers, medicines used in substitution treatment and some antitussive medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression) and coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered if other treatment options are not possible.
If, however, a doctor prescribes Klonafen together with opioids, the doctor should limit the dose and duration of concomitant treatment.
Inform the doctor about all opioid medicines being taken and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or family members about the objective and subjective symptoms described above. If such symptoms occur, contact a doctor.
Surgery
If general anaesthesia is planned for a surgical or dental procedure, it is important to inform the doctor or dentist about taking Klonafen.
Klonafen and alcohol
Do not drink alcohol while taking Klonafen. The reason is the risk of adverse effects. Alcohol may also enhance the effect of Klonafen, which may lead to severe sedation, potentially resulting in coma or death.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before taking this medicine.
Treatment with Klonafen should not be discontinued during pregnancy without the doctor's consent, because abrupt discontinuation of treatment or uncontrolled dose reduction may lead to epileptic seizures during pregnancy, which may harm the mother or unborn child. Clonazepam may be used during pregnancy only when clearly indicated and according to the doctor's recommendations. It is known to have harmful effects on the unborn child.
Clonazepam should not be used during breastfeeding. If clonazepam use is necessary, breastfeeding must be discontinued.
Driving and operating machinery
Talk to the doctor about driving and operating machinery or tools while taking Klonafen. This medicine may slow down reactions, especially at the beginning of treatment. If in doubt whether the patient can perform a particular activity, consult a doctor.
Dependence
There is a risk of dependence while taking this medicine, which increases with dose and duration of treatment, as well as in patients with a history of alcoholism and/or drug or medicine abuse.
Klonafen contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking the medicine.

3. How to take Klonafen

Klonafen must always be taken exactly as directed by the doctor. In case of doubt, consult your doctor.
The doctor should individually adjust the dose of Klonafen for each patient based on age, response to treatment, and tolerance.
For infants and children, a different pharmaceutical form (oral solution) is considered more appropriate.
To avoid adverse effects at the beginning of treatment, it is important to start with a low initial dose, for example:
Infants and children (≤10 years of age or ≤30 kg body weight): 0.01 mg/kg body weight per day to 0.05 mg/kg body weight per day.
Children (>10 years of age or >30 kg body weight): 0.25 mg twice daily.
Adolescents (aged 13 to 18 years) and adults: 0.5 mg twice daily.
The dose should be gradually increased until the required maintenance daily dose is reached.
The maintenance daily dose should be achieved over a period of 2 to 4 weeks of treatment.
Depending on age, maintenance doses may be administered according to the following recommendations:
For infants and children up to 10 years of age or with body weight up to 30 kg, the maintenance dose is 0.1 to 0.2 mg/kg body weight per day.
Dose in mg
Children (>10 years or >30 kg body weight) 3–6
Adolescents (aged 13 to 18 years) and adults 4–8
Daily doses should be divided into 3 or 4 single doses per day; if necessary, they may be increased.
The maximum recommended dose in adults is 20 mg per day.
Elderly patients
In elderly patients, the lowest possible dose should be used. Particular caution should be exercised in elderly individuals, especially during gradual dose escalation.
Renal impairment
Dose adjustment is not necessary in these patients.
Hepatic impairment
Patients with severe hepatic impairment should not be treated with this medicinal product (see section 2). In patients with mild or moderate hepatic impairment, the lowest possible dose should be used.
Method of administration
The tablets are for oral use. Tablets should be swallowed whole, without chewing, with a small amount of liquid.
Tablets may be divided into 2 or 4 equal doses depending on the tablet strength (see section 6).
Taking more than the recommended dose of Klonafen
If more than the recommended dose of Klonafen is taken, contact your doctor immediately or go to hospital. Take the medicine pack with you.
If too many tablets are taken, symptoms such as drowsiness, somnolence, feeling of emptiness in the head, lack of coordination, or reduced response to stimuli may occur.
Missing a dose of Klonafen
If a patient forgets to take a dose, that dose should be omitted. The next dose should be taken at the usual time.
Do not take a double dose (two doses at the same time) to make up for a missed dose.
Stopping Klonafen
If a patient has been treated with Klonafen for a long time (i.e. the medicine has been administered for an extended period), dependence on this medicine may develop and withdrawal symptoms may occur (see section 4).

• Do not stop taking the tablets without consulting your doctor. In such a case, seizures may return and withdrawal symptoms may occur (see sections 2 and 4).
• If dose reduction or discontinuation of Klonafen is necessary, it must be done gradually. Your doctor will inform you how to do this.

If someone else accidentally takes Klonafen tablets, they should immediately speak to a doctor or go to hospital.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Klonafen may cause adverse effects, although not everyone experiences them.
You should tell your doctor immediately if the patient feels unwell due to the medicine,
or if the patient experiences any of the following symptoms:

• Sudden swelling of the throat, face, lips, or mouth. This may make breathing or swallowing difficult.
• Sudden swelling of the hands, feet, and ankles.
• Skin rash or itching.
• Shortness of breath, ankle swelling, cough, fatigue, and rapid heartbeat.
• Chest pain, which may radiate to the neck, shoulders, and left arm.
• Aggression, hyperactivity, irritability, nervousness, agitation, hostility, or restlessness.
• Sleep disturbances, nightmares, and unusual dreams.
• Psychiatric disturbances such as seeing or hearing things that are not real (hallucinations), delusions (belief in things that are not true), and speech problems.
• Inappropriate behavior, emotional changes, and mood changes.
• Seizures that have not occurred previously.
• Breathing problems (respiratory depression). Early symptoms include sudden loud, labored, and irregular breathing. The skin may turn blue.

Other possible adverse effects
Common (occurring in up to 1 in 10 people)

• Drowsiness and fatigue
• Slowed reaction time
• Muscle weakness or floppiness
• Difficulty concentrating
• Dizziness
• Involuntary eye movements (nystagmus)
• Feeling tired
• Unsteady movements and gait (ataxia)

Uncommon (occurring in up to 1 in 1,000 people)

• Symptoms such as fatigue, easy bruising, shortness of breath, and nosebleeds, which may indicate blood disorders.
• Nausea
• Headache
• Stomach upset
• Skin rashes, hives (raised rash), and skin itching
• Change in skin pigmentation
• Hair loss (hair usually regrows)
• Changes in sex drive
• Difficulty achieving or maintaining erection (erectile dysfunction)
• Urine leakage (urinary incontinence)

Rare (occurring in up to 1 in 10,000 people)

• Generalized seizures

Frequency not known (cannot be estimated from available data)

• Jerky movements (coordination disturbances)
• Confusion and disorientation
• Restlessness
• Unsteadiness when walking
• Difficulty remembering new things
• Depression
• Double vision
• Risk of falls and bone fractures – this usually affects elderly people and those taking other sedative medicines (or alcohol).

Description of selected adverse effects
Medical literature indicates that the use of benzodiazepines (a group of medicines used to treat seizures and sleep disorders) may increase the risk of pneumonia (lung infection).
Withdrawal symptoms
Klonazepam may cause primary dependence. The use of benzodiazepines such as Klonafen may lead to dependence on the medicine. This means that if treatment is stopped abruptly or the dose is reduced too quickly, withdrawal symptoms may occur.
Symptoms may include:

• Sleep disturbances
• Muscle pain, tremors, and restlessness
• Feelings of anxiety, tension, confusion, irritability, or agitation, or mood changes
• Increased sweating
• Headache
• Diarrhea
  Less common withdrawal symptoms include:
• Sensitivity to light, noise, and physical touch
• Seeing or hearing things that are not real (hallucinations)
• Tingling and numbness in hands and feet
• Feeling of detachment from reality

Other adverse effects in infants and children

• If an infant or young child is taking Klonafen, they should be closely observed, as breathing problems, cough, or choking may occur. This may be due to increased bronchial and salivary secretions.
• Early sexual maturation in children. This is reversible after discontinuation of Klonafen.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Klonafen

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep the blisters in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP".
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Tablets should be kept only on a doctor's advice.

6. Contents of the pack and other information

What Klonafen contains
The active substance in Klonafen is clonazepam.
Klonafen, 0.5 mg, tablets
Each tablet contains 0.5 mg of clonazepam.
Klonafen, 2 mg, tablets
Each tablet contains 2 mg of clonazepam.
The other ingredients are:
monohydrate lactose
microcrystalline cellulose type 102
pregelatinized corn starch
magnesium stearate

What Klonafen looks like and contents of the pack
Klonafen, 0.5 mg
White or almost white, elongated, flat tablets with a score line on one side.
Size: 9 mm x 4.5 mm.
The tablet can be divided into two equal doses.

Klonafen, 2 mg
White or almost white, round, flat tablets with a cross-shaped score line on one side.
Diameter: 7 mm.
The tablet can be divided into two or four equal doses.

Packaging: 14, 20, 30, 50, 60, 100 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
ul. A. Fleminga 2
03-176 Warsaw
Telephone number: (22) 811 18 14
To obtain further information on this medicinal product, please contact the Marketing Authorisation Holder.

This medicinal product is authorised in the European Economic Area countries under the following names:

• Poland Klonafen
• Italy Clonazepam TZF
• Spain Clonazepam TZF, 0.5 mg, 2 mg, comprimidos
• Netherlands Clonazepam TZF 0.5 mg, 2 mg, tabletten
• Portugal Clonazepam TZF